Social Anxiety DisorderNCT01746667
Virtual Reality Exposure Therapy Versus Exposure in Vivo for Social Phobia
A study testing Exposure in vivo and Virtual Reality Exposure Therapy in people with Social Anxiety Disorder and Social Phobia, run by VU University of Amsterdam at 1 site in Netherlands.
Trial summary
The current study aims at comparing the efficacy of exposure in vivo and exposure via virtual reality for social anxiety disorder. 70 patients with social anxiety disorder will be randomized to either one of the active conditions or to a waiting-list condition. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder, Social Phobia
- What is being tested?
- Exposure in vivo and Virtual Reality Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2012to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 65 years old
- a primary diagnosis of social anxiety disorder as measured with the SCID
- fluency in Dutch.
Who cannot join
- psychotic episodes in the past, suicidal intentions or substance dependence.
- behavior therapy in the preceding one year.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University of Amsterdam, Department of Clinical Psychology
Amsterdam, 1018 XA
About this study
The current study aims at comparing the efficacy of exposure in vivo and exposure via virtual reality for social anxiety disorder. 70 patients with social anxiety disorder will be randomized to either one of the active conditions or to a waiting-list condition. Participants on the waiting-list will be offered either exposure in vivo of in virtual reality after a waiting period of five weeks. Levels of psychopathology will be assessed at pre- and post-treatment as well as three and 12 months after treatment.
- Conditions
- Social Anxiety Disorder, Social Phobia
- Being tested
- Exposure in vivo, Virtual Reality Exposure Therapy
- Keywords
- Social Anxiety Disorder, Social Phobia, Virtual Reality, Exposure
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure in vivoBehavioural
Also called Behavior Therapy
Virtual Reality Exposure TherapyBehavioural
Also called Virtual Reality Therapy
| Study group | Role | What they receive |
|---|---|---|
| Exposure in vivo | Experimental | This treatment will consist of 10 sessions (twice a week) of exposure therapy based on the protocol used previously in exposure therapy for social anxiety disorder by Scholing \& Emmelkamp (1993). Receives: Behavioral: Exposure in vivo |
| Virtual Reality Exposure Therapy | Experimental | This treatment consists of 10 sessions (twice a week) of exposure therapy by using virtual environments.
The difference between the exposure in vivo and virtual reality exposure therapy is the exposure component, which will be delivered in vivo in one condition and through the Head Mounted Display (HMD) in the other condition. Receives: Behavioral: Virtual Reality Exposure Therapy |
| Wait-list | No intervention | Participants on the wait-list will be offered either exposure in vivo or in virtual reality after a waiting period of five weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline: Liebowitz Social Anxiety Scale-Self report
Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.
Measured: Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.
Change from baseline: Fear of Negative Evaluation Scale
Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.
Measured: Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.
Secondary outcomes (5)
Change from baseline: Behavioral Assessment Task (BAT), Public Speaking Performance Scale
The BAT consists of a videotaped 5 minute impromptu speech in front of two confederates. The Public Speaking Performance Scale will be used to evaluate the performance during the speech, both by patients and indipendent raters.
Change from pre-treatment to post-treatment (5 weeks) will be examined.
Measured: Pre-treatment to post-treatment (5 weeks)
Change from baseline: Structured Clinical Interview for DSM-IV (Social Phobia Module)
Change in diagnosis of Social Phobia from pre-treatment to three months follow-up.
Measured: Pre-treatment to three months follow-up.
Change from baseline: Depression Anxiety Stress Scale
Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.
Measured: Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up.
Change from baseline: Personality Disorder Belief Questionnaire
Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.
Measured: Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up.
Change from baseline: Eurohis Quality of Life Scale
Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.
Measured: Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul M.G.Emmelkamp, VU University of Amsterdam
- Investigators
- Paul GM Emmelkamp, PhD, Principal investigator, University of AmsterdamNexhmedin Morina, PhD, Study director, University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746667
- Sponsor's protocol ID
- 05510207
- Status last verified
- Feb 2017
- First submitted
- 19 Nov 2012
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kampmann IL, Emmelkamp PMG, Morina N. Cognitive predictors of treatment outcome for exposure therapy: do changes in self-efficacy, self-focused attention, and estimated social costs predict symptom improvement in social anxiety disorder? BMC Psychiatry. 2019 Feb 22;19(1):80. doi: 10.1186/s12888-019-2054-2.
PubMed 30795749
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Exposure Therapy Versus Exposure in Vivo for Social Phobia
- ClinicalTrials.gov ID
- NCT01746667
- Acronym / sponsor ID
- 05510207
- Conditions
- Social Anxiety Disorder, Social Phobia
- Keywords
- Social Anxiety Disorder, Social Phobia, Virtual Reality, Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 11 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study aims at comparing the efficacy of exposure in vivo and exposure via virtual reality for social anxiety disorder. 70 patients with social anxiety disorder will be randomized to either one of the active conditions or to a waiting-list condition. Participants on the waiting-list will be offered either exposure in vivo of in virtual reality after a waiting period of five weeks. Levels of psychopathology will be assessed at pre- and post-treatment as well as three and 12 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exposure in vivo | Experimental | Behavioral: Exposure in vivoThis treatment will consist of 10 sessions (twice a week) of exposure therapy based on the protocol used previously in exposure therapy for social anxiety disorder by Scholing \& Emmelkamp (1993). |
| Virtual Reality Exposure Therapy | Experimental | Behavioral: Virtual Reality Exposure TherapyThis treatment consists of 10 sessions (twice a week) of exposure therapy by using virtual environments. The difference between the exposure in vivo and virtual reality exposure therapy is the exposure component, which will be delivered in vivo in one condition and through the Head Mounted Display (HMD) in the other condition. |
| Wait-list | No intervention | –Participants on the wait-list will be offered either exposure in vivo or in virtual reality after a waiting period of five weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 - 65 years old
- a primary diagnosis of social anxiety disorder as measured with the SCID
- fluency in Dutch.
Key exclusion criteria (2 listed)
- psychotic episodes in the past, suicidal intentions or substance dependence.
- behavior therapy in the preceding one year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure in vivoAlso: Behavior Therapy | Behavioural | Exposure in vivo |
| Virtual Reality Exposure TherapyAlso: Virtual Reality Therapy | Behavioural | Virtual Reality Exposure Therapy |
Primary outcome
Change from baseline: Liebowitz Social Anxiety Scale-Self report
Time frame: Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.
Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.
Change from baseline: Fear of Negative Evaluation Scale
Time frame: Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.
Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.
5 secondary outcomes
Change from baseline: Behavioral Assessment Task (BAT), Public Speaking Performance Scale
Time frame: Pre-treatment to post-treatment (5 weeks)
Change from baseline: Structured Clinical Interview for DSM-IV (Social Phobia Module)
Time frame: Pre-treatment to three months follow-up.
Change from baseline: Depression Anxiety Stress Scale
Time frame: Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up.
Change from baseline: Personality Disorder Belief Questionnaire
Time frame: Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up.
Change from baseline: Eurohis Quality of Life Scale
Time frame: Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- Derived from this study: PubMed 30795749Kampmann IL, Emmelkamp PMG, Morina N. Cognitive predictors of treatment outcome for exposure therapy: do changes in self-efficacy, self-focused attention, and estimated social costs predict symptom improvement in social anxiety disorder? BMC Psychiatry. 2019 Feb 22;19(1):80. doi: 10.1186/s12888-019-2054-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul GM Emmelkamp, PhD principal investigator
University of Amsterdam
Nexhmedin Morina, PhD study director
University of Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure in vivo and Virtual Reality Exposure Therapy in people with Social Anxiety Disorder and Social Phobia, run by VU University of Amsterdam at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline: Liebowitz Social Anxiety Scale-Self report (time frame: Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01746667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.